Problem
Conceptualization and the extent of the problem
Medicine safety can be seen to be traditionally divided into three distinct areas:
The safety of the drug itself, patient compliant issues and the safe and appropriate
use by healthcare professionals. These latter "medication errors" include errors
in the prescribing, dispensing, preparation, administering and monitoring of medicines.
Within clinical trials prescribing and dispensing errors pose significant problem
which despite much work have to date, appeared to be a fairly intractable problem.
However, this is now amenable to intervention.
There are several reasons why this is the case. First, our understanding through
the work of "CliniSafe's working Group" on the causes of medication error in clinical
trial environment has taken substantial steps forward in recent years. This can
also be said of the development of change tools and strategies which can be brought
to bear to improve the situation. What is more, structural changes to the clinical
trial environment and the rapid development of information technology are enabling
new ways of working that begin to look at the whole system rather than the individual
practitioner or act.
Solution
The role of technology in improving medicines safety.
the 'science of safety'
Technology has great potential to improve medicines safety. Its ability to handle
large amounts of information, to use it to support decisions, and to repeatedly
perform the same act, brings many benefits. The effectiveness of technology however
depends on context. A technology shown to reduce errors in one system may have a
very limited effect in another.
At CliniSafe in 2004 a "working group" was established to understand the practical
aspects of concomitant medication safety system design within the clinical trial
environment and the factors underpinning safe systems of work.
Understanding systems thinking, safety culture and the role of human factors is
at the heart of our work.
Creating a Safety System
Safety systems in clinical research seek to prevent harm to clinical trial subjects.
It is now widely recognised that errors and human behaviour cannot be understood
in isolation, but must be considered in the context or system in which people are
working.
Using a system's approach CliniSafe® now provides an alternative to ineffective
or potentially harmful practice and provides a new 'gold standard' for drug checking
within clinical trials.
The Award Winning System was created to provide a clinical trial web-based programme
to both minimize and mitigate risk associated with errors related to the ever increasingly
complex area of drug concomitant medication management.
CliniSafe® reduces error, improving data accuracy and safety. It creates a system
in which the default option - the easiest option when the decision is complicated
or you are tired or distracted - is always the right option for the subject.
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